ANDA 061996

CHARTWELL RX

FDA Drug Application

Application #061996

Application Sponsors

ANDA 061996

CHARTWELL RX

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	125MG	0	FULVICIN P/G	GRISEOFULVIN, ULTRAMICROCRYSTALLINE
002	TABLET;ORAL	250MG	0	FULVICIN P/G	GRISEOFULVIN, ULTRAMICROCRYSTALLINE
003	TABLET;ORAL	165MG	0	FULVICIN P/G 165	GRISEOFULVIN, ULTRAMICROCRYSTALLINE
004	TABLET;ORAL	330MG	0	FULVICIN P/G 330	GRISEOFULVIN, ULTRAMICROCRYSTALLINE

FDA Submissions

	ORIG	1	AP	1982-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-01-26

Submissions Property Types

SUPPL

7

Null

0

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61996
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVICIN P\/G","activeIngredients":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FULVICIN P\/G","activeIngredients":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FULVICIN P\/G 165","activeIngredients":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","strength":"165MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FULVICIN P\/G 330","activeIngredients":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","strength":"330MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FULVICIN P\/G","submission":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","actionType":"125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FULVICIN P\/G","submission":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FULVICIN P\/G 165","submission":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","actionType":"165MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FULVICIN P\/G 330","submission":"GRISEOFULVIN, ULTRAMICROCRYSTALLINE","actionType":"330MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)